Chronic Hepatitis CPhase 2NCT01842451
A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-135 and Daclatasvir in Subjects With Genotype 1 Chronic Hepatitis C Chronic Hepatitis C
A Phase 2 study testing VX-135 and Daclatasvir in people with Chronic Hepatitis C and CHC, run by Vertex Pharmaceuticals Incorporated at 2 sites in New Zealand.
Trial summary
A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-135 and Daclatasvir in Treatment-Naïve Adult Subjects With Genotype 1 Chronic Hepatitis C Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Hepatitis C, CHC, HCV
- What is being tested?
- VX-135 and Daclatasvir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesNew Zealand
- Study dates
- Jun 2013to May 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects must have genotype 1 CHC and evidence of HCV infection at least 6 months before screening
- Subjects must be treatment-naïve and have not received prior treatment with any interferon, immunomodulatory agent, or DAA for HCV
Who cannot join
- Evidence of cirrhosis
- History or other clinical evidence of significant or unstable cardiac disease
- Any other cause of significant liver disease in addition to hepatitis C
- Creatinine clearance ≤50 mL/min using the Cockcroft-Gault equation at screening
- Female subjects who are pregnant or nursing
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Phase 2, Multicenter, Randomized, Partially-Blind, Dose-Ranging Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-135 and Daclatasvir in Treatment-Naïve Adult Subjects With Genotype 1 Chronic Hepatitis C
A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-135 and Daclatasvir in Treatment-Naïve Adult Subjects With Genotype 1 Chronic Hepatitis C
- Conditions
- Chronic Hepatitis C, CHC, HCV, Hepatitis C
- Being tested
- VX-135, Daclatasvir
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VX-135Drug
DaclatasvirDrug
| Study group | Role | What they receive |
|---|---|---|
| VX-135 High Dose with Daclatasvir | Experimental | 12 weeks of a high dose of VX-135 in combination with Daclatasvir Receives: Drug: VX-135; Drug: Daclatasvir |
| VX-135 Low Dose with Daclatasvir | Experimental | 12 weeks of a low dose of VX-135 in combination with Daclatasvir Receives: Drug: VX-135; Drug: Daclatasvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), echocardiograms, and laboratory assessments
Measured: Up to 64 weeks
Secondary outcomes (8)
The proportion of subjects who have a sustained virologic response (SVR; i.e., HCV RNA concentration below the lower limit of quantitation [<LLOQ; <25 IU/mL]) at 4 weeks after the last planned dose of treatment (SVR4)
Measured: Up to 20 Weeks
The proportion of subjects who have an SVR at 12 weeks after the last planned dose of treatment (SVR12)
Measured: Up to 28 weeks
The proportion of subjects who have an SVR at 44 weeks after the last planned dose of treatment (SVR24)
Measured: Up to 40 weeks
The proportion of subjects who have virologic relapse
Measured: Up to 64 weeks
The proportion of subjects who have virologic breakthrough
Measured: Up to 16 weeks
The amino acid sequence of the nonstructural NS5A and NS5B proteins in subjects who have treatment failure
Measured: Up to 64 weeks
The proportion of subjects who achieve SVR12 by HCV genotype 1 subtype (1a versus non-1a)
Measured: Up to 28 weeks
The proportion of subjects who achieve SVR12 by IL-28B genotype (CC versus non-CC)
Measured: Up to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2013 (estimated)
- Study startJun 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by Vertex Pharmaceuticals IncorporatedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01842451
- Sponsor's protocol ID
- VX13-135-105
- Status last verified
- Nov 2015
- First submitted
- 24 Apr 2013
- Last updated
- 29 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Partially-Blind, Dose-Ranging Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-135 and Daclatasvir in Treatment-Naïve Adult Subjects With Genotype 1 Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT01842451
- Acronym / sponsor ID
- VX13-135-105
- Conditions
- Chronic Hepatitis C, CHC, HCV, Hepatitis C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 29 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-135 and Daclatasvir in Treatment-Naïve Adult Subjects With Genotype 1 Chronic Hepatitis C
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VX-135 High Dose with Daclatasvir | Experimental | Drug: VX-135, Drug: Daclatasvir12 weeks of a high dose of VX-135 in combination with Daclatasvir |
| VX-135 Low Dose with Daclatasvir | Experimental | Drug: VX-135, Drug: Daclatasvir12 weeks of a low dose of VX-135 in combination with Daclatasvir |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects must have genotype 1 CHC and evidence of HCV infection at least 6 months before screening
- Subjects must be treatment-naïve and have not received prior treatment with any interferon, immunomodulatory agent, or DAA for HCV
Key exclusion criteria (5 listed)
- Evidence of cirrhosis
- History or other clinical evidence of significant or unstable cardiac disease
- Any other cause of significant liver disease in addition to hepatitis C
- Creatinine clearance ≤50 mL/min using the Cockcroft-Gault equation at screening
- Female subjects who are pregnant or nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VX-135 | Drug | VX-135 High Dose with Daclatasvir, VX-135 Low Dose with Daclatasvir |
| Daclatasvir | Drug | VX-135 High Dose with Daclatasvir, VX-135 Low Dose with Daclatasvir |
Primary outcome
The safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), echocardiograms, and laboratory assessments
Time frame: Up to 64 weeks
8 secondary outcomes
The proportion of subjects who have a sustained virologic response (SVR; i.e., HCV RNA concentration below the lower limit of quantitation [<LLOQ; <25 IU/mL]) at 4 weeks after the last planned dose of treatment (SVR4)
Time frame: Up to 20 Weeks
The proportion of subjects who have an SVR at 12 weeks after the last planned dose of treatment (SVR12)
Time frame: Up to 28 weeks
The proportion of subjects who have an SVR at 44 weeks after the last planned dose of treatment (SVR24)
Time frame: Up to 40 weeks
The proportion of subjects who have virologic relapse
Time frame: Up to 64 weeks
The proportion of subjects who have virologic breakthrough
Time frame: Up to 16 weeks
The amino acid sequence of the nonstructural NS5A and NS5B proteins in subjects who have treatment failure
Time frame: Up to 64 weeks
The proportion of subjects who achieve SVR12 by HCV genotype 1 subtype (1a versus non-1a)
Time frame: Up to 28 weeks
The proportion of subjects who achieve SVR12 by IL-28B genotype (CC versus non-CC)
Time frame: Up to 28 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VX-135 and Daclatasvir in people with Chronic Hepatitis C and CHC, run by Vertex Pharmaceuticals Incorporated at 2 sites in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), echocardiograms, and laboratory assessments (time frame: Up to 64 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2015.